The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Randomized Controlled Trial.
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SUBMITTER: Ruiz-Zaldibar C
PROVIDER: S-EPMC9656642 | biostudies-literature | 2022 Oct
REPOSITORIES: biostudies-literature
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The Effect of a Sleep Intervention on Sleep Quality in Nursing Students: Study Protocol for a Randomized Controlled Trial.
Ruiz-Zaldibar Cayetana C Gal-Iglesias Beatriz B Azpeleta-Noriega Clara C Ruiz-López Montserrat M Pérez-Manchón David D
International journal of environmental research and public health 20221025 21
We develop a protocol for assessing the impact of an intervention aimed at improving sleep quality among university nursing students. The study is designed as a pilot randomized controlled trial to be applied during the 2022-23 academic year and is registered at Clinical Trials Gov website (NCT05273086). A total of 60 nursing students will be recruited from a Spanish university. They will be divided into two groups: (30) intervention group and (30) control group. The intervention group will atte ...[more]
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Project description:BackgroundEmbarking on a university education is a significant milestone in a person's life. However, evidence shows that many students face poor sleep quality and academic self-doubt during this period. This study aimed to determine the effect of Orem self-care interventions on sleep quality and the academic self-efficacy of nursing students.MethodsThis quasi-experimental study employed a pre-test and post-test control group design to evaluate the intervention's effects. The study was conducted between October 23 and November 10, 2023, and included 84 nursing students. The participants were randomly divided into two groups: an intervention group and a control group. The tools used were a demographic questionnaire, an Orem self-care model survey and recognition form, the Zajacova Academic Self-Efficacy Beliefs Questionnaire, and the Pittsburgh Sleep Quality Index. The experimental group's intervention, grounded in Orem's self-care model, included four sessions, each lasting 30 to 45 min. These sessions addressed self-care principles, techniques related to universal needs (like air, water, food, and excretory processes), and strategies for risk prevention while ensuring a balance between activity and rest. There were no follow-up interventions after the initial training sessions. At the end of the intervention, all students in both groups had completed the study instruments. The data was analyzed using SPSS version 26 software, which included the chi-square test, Independent-samples t-test, Mann-Whitney U test, Paired-samples t-test, and Wilcoxon signed rank test.ResultsThe results showed that before the intervention, there was no statistically significant difference in the average total sleep quality score (7.64 ± 2.48 in the experimental group versus 7.42 ± 2.74 in the control group) or academic self-efficacy (148.38 ± 12.10 in the experimental group versus 144.66 ± 10 in the control group) between the two groups. However, after the intervention, there were significant changes in the experimental group's total sleep quality score (3.80 ± 1.56) and academic self-efficacy score (170.71 ± 10.58) compared to the control group's total sleep quality score (7.80 ± 2.81) and academic self-efficacy score (149.42 ± 11).ConclusionIn other words, interventions based on Orem's self-care positively affect students' sleep quality and academic self-efficacy. Based on the results, a self-care program based on the Orem model for nursing students can improve their sleep quality and academic self-efficacy. Therefore, it is recommended that this model be used for students in educational environments.
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Project description:Patients in coronary care unit are at risk of sleep deprivation. Sleep deprivation can be associated with increased blood pressure and heart rate, raising the risk of developing cardiovascular problems among patients hospitalized in coronary care unit.This study was carried out to examine the effect of eye mask on sleep quality in cardiac patients.In this randomized controlled trial, 60 patients who met the inclusion criteria were selected using a convenient sampling method and randomly allocated into the experimental and control groups. Patients in the control group received routine care. However, in the experimental group, patients received routine care and eye mask for three subsequent nights. In the both groups, the sleep quality was assessed using the Pittsburgh sleep quality index. Data were analyzed by the chi-square test, independent samples t-test, Mann-Whitney U, and Wilcoxon signed-rank tests.After the study, the median scores of the subjective sleep quality, the sleep latency, the sleep duration, the habitual sleep efficiency, and the sleep disturbances domains, as well as the median score of overall Pittsburgh sleep quality index in the experimental group were significantly lower than those in the control group (P < 0.05). However, no significant differences were observed between the two groups in terms of the use of sleep medications and the daytime dysfunction domains (P > 0.05).Using eye mask can significantly improve the sleep quality in cardiac patients. Therefore, nurses are recommended to use eye mask in combination with current treatments for improving patients' sleep quality.
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Project description:To evaluate the efficacy of a 12-week exercise training program for reducing obstructive sleep apnea (OSA) severity and improving sleep quality, and to explore possible mechanisms by which exercise may reduce OSA severity.Randomized controlled trial.Clinical exercise physiology center, sleep laboratory.Forty-three sedentary and overweight/obese adults aged 18-55 years with at least moderate-severity untreated OSA (screening apnea-hypopnea index [AHI] ? 15).Participants randomized to exercise training (n = 27) met 4 times/week for 12 weeks and performed 150 min/week of moderate-intensity aerobic activity, followed by resistance training twice/week. Participants randomized to a stretching control (n = 16) met twice weekly for 12 weeks to perform low-intensity exercises designed to increase whole-body flexibility.OSA severity was assessed with one night of laboratory polysomnography (PSG) before and following the 12-week intervention. Measures of sleep quality included PSG, actigraphy (7-10 days), and the Pittsburgh Sleep Quality Index. Compared with stretching, exercise resulted in a significant AHI reduction (exercise: 32.2 ± 5.6 to 24.6 ± 4.4, stretching: 24.4 ± 5.6 to 28.9 ± 6.4; P < 0.01) as well as significant changes in oxygen desaturation index (ODI; P = 0.03) and stage N3 sleep (P = 0.03). Reductions in AHI and ODI were achieved without a significant decrease in body weight. Improvements in actigraphic sleep and subjective sleep quality were also noted following exercise compared with stretching.Exercise training had moderate treatment efficacy for the reduction of AHI in sedentary overweight/obese adults, which suggests that exercise may be beneficial for the management of OSA beyond simply facilitating weight loss.Clinicaltrials.gov identification number NCT00956423.
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Project description:BackgroundSleep problems in childhood have been found to be associated with memory and learning impairments, irritability, difficulties in mood modulation, attention and behavioral problems, hyperactivity and impulsivity. Short sleep duration has been found to be associated with overweight and obesity in childhood. This paper describes the protocol of a behavioral intervention planned to promote healthier sleep in infants.MethodsThe study is a 1:1 parallel group single-blinded randomized controlled trial enrolling a total of 552 infants at 3 months of age. The main eligibility criterion is maternal report of the infant's sleep lasting on average less than 15 h per 24 h (daytime and nighttime sleep). Following block randomization, trained fieldworkers conduct home visits of the intervention group mothers and provide standardized advice on general practices that promote infant's self-regulated sleep. A booklet with the intervention content to aid the mother in implementing the intervention was developed and is given to the mothers in the intervention arm. In the two days following the home visit the intervention mothers receive daily telephone calls for intervention reinforcement and at day 3 the fieldworkers conduct a reinforcement visit to support mothers' compliance with the intervention. The main outcome assessed is the between group difference in average nighttime self-regulated sleep duration (the maximum amount of time the child stays asleep or awake without awakening the parents), at ages 6, 12 and 24 months, evaluated by means of actigraphy, activity diary records and questionnaires. The secondary outcomes are conditional linear growth between age 3-12 and 12-24 months and neurocognitive development at ages 12 and 24 months.DiscussionThe negative impact of inadequate and insufficient sleep on children's physical and mental health are unquestionable, as well as its impact on cognitive function, academic performance and behavior, all of these being factors to which children in low- and middle-income countries are at higher risk. Behavioral interventions targeting mothers and young children that can be delivered inexpensively and not requiring specialized training can help prevent future issues by reducing the risk to which these children are exposed.Trial registrationClinicalTrial.gov NCT02788630 registered on 14 June 2016 (retrospectively registered).
| S-EPMC5010682 | biostudies-literature
Project description:BackgroundBladder surgery has a negative impact on patients' mental health, sleep quality. Conventional nursing interventions failed to meet the clinical needs. Therefore, this parallel-group RCT was performed to assess the effect of individualized psychological intervention on patients' negative emotions and sleep quality after bladder cancer surgery.MethodsPatients with bladder cancer admitted to our hospital (from September 2018 to October 2020) and underwent surgical treatment were selected as the research objects. They were randomly allocated to a parallel control group or observation group based on a computer-generated random numbers table. Because our study included behavioral intervention, blinding was not possible for participants and care givers. The control group received conventional nursing care, and the observation group received strengthened individualized psychological intervention under the nursing measures of the control group. Sleep quality, anxiety, depression, nursing compliance, and the occurrence of bladder spasm were compared between the two groups.ResultsSeventy-eight eligible patients were included and randomly divided in two groups (n=39 for each group). The intervention procedure was completed without losses and exclusions of patients after randomization. Before the intervention, the Pittsburgh Sleep Quality Index Scale and the anxiety and depression scores were comparable between the two groups (P>0.05). After the intervention, the data of the two groups were significantly improved. The sleep quality, sleep time, sleep efficiency, the time to fall asleep, hypnotic drugs, sleep disorders, daytime dysfunction, anxiety score, and depression score of the observation group were lower than those of the control group, with significant differences (P<0.05). The total nursing compliance rate of the observation group reached 100.00%, which was higher than the control group. The difference between the groups was significant (P<0.05). There was no significant difference in the incidence of bladder spasm between the two groups (P>0.05).ConclusionsIndividualized psychological intervention applied to bladder cancer surgery can effectively improve patients' negative emotions and improve their sleep quality.Trial registrationChinese Clinical Trial Registry ChiCTR2100046468.
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Project description:BackgroundPneumonia remains an important public health problem among elderly nursing home residents. This clinical trial sought to determine if a multicomponent intervention protocol, including manual tooth/gum brushing plus 0.12% chlorhexidine oral rinse, twice per day, plus upright positioning during feeding, could reduce the incidence of radiographically documented pneumonia among nursing home residents, compared with usual care.MethodsThis cluster-randomized clinical trial was conducted in 36 nursing homes in Connecticut. Eligible residents >65 years with at least 1 of 2 modifiable risk factors for pneumonia (ie, impaired oral hygiene, swallowing difficulty) were enrolled. Nursing homes were randomized to the multicomponent intervention protocol or usual care. Participants were followed for up to 2.5 years for development of the primary outcome, a radiographically documented pneumonia, and secondary outcome, a lower respiratory tract infection (LRTI) without radiographic documentation.ResultsA total of 834 participants were enrolled: 434 to intervention and 400 to usual care. The trial was terminated for futility. The number of participants in the intervention vs control arms with first pneumonia was 119 (27.4%) vs 94 (23.5%), respectively, and with first LRTI, 125 (28.8%) vs 100 (25.0%), respectively. In a multivariable Cox regression model, the hazard ratio in the intervention vs control arms, respectively, was 1.12 (95% confidence interval [CI], .84-1.50; P = .44) for first pneumonia and 1.07 (95% CI, .79-1.46, P = .65) for first LRTI.ConclusionsThe multicomponent intervention protocol did not significantly reduce the incidence of first radiographically confirmed pneumonia or LRTI compared with usual care in nursing home residents.Clinical trials registrationNCT00975780.
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Project description:BackgroundObstructive sleep apnea (OSA) and hypertension are well-known cardiovascular risk factors. Their control could reduce the burden of heart disease across populations. Several drugs are used to control hypertension, but the only consistently effective treatment of OSA is continuous positive airway pressure. The identification of a drug capable of improving OSA and hypertension simultaneously would provide a novel approach in the treatment of both diseases.Methods/designThis is a randomized double-blind clinical trial, comparing the use of chlorthalidone with amiloride versus amlodipine as a first drug option in patients older than 40 years of age with stage I hypertension (140 to 159/90 to 99 mmHg) and moderate OSA (15 to 30 apneas/hour of sleep). The primary outcomes are the variation of the number of apneas per hour and blood pressure measured by ambulatory blood pressure monitoring. The secondary outcomes are adverse events, somnolence scale (Epworth), ventilatory parameters and C reactive protein levels. The follow-up will last 8 weeks. There will be 29 participants per group. The project has been approved by the ethics committee of our institution.DiscussionThe role of fluid retention in OSA has been known for several decades. The use of diuretics are well established in treating hypertension but have never been appropriately tested for sleep apnea. As well as testing the efficacy of these drugs, this study will help to understand the mechanisms that link hypertension and sleep apnea and their treatment.Trial registrationClinicalTrials.gov: NCT01896661.
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Project description:ImportanceInadequate adherence to recommendations known to reduce the risk of sudden unexpected infant death has contributed to a slowing in the decline of these deaths.ObjectiveTo assess the effectiveness of 2 interventions separately and combined to promote infant safe sleep practices compared with control interventions.Design, setting, and participantsFour-group cluster randomized clinical trial of mothers of healthy term newborns who were recruited between March 2015 and May 2016 at 16 US hospitals with more than 100 births annually. Data collection ended in October 2016.InterventionsAll participants were beneficiaries of a nursing quality improvement campaign in infant safe sleep practices (intervention) or breastfeeding (control), and then received a 60-day mobile health program, in which mothers received frequent emails or text messages containing short videos with educational content about infant safe sleep practices (intervention) or breastfeeding (control) and queries about infant care practices.Main outcomes and measuresThe primary outcome was maternal self-reported adherence to 4 infant safe sleep practices of sleep position (supine), sleep location (room sharing without bed sharing), soft bedding use (none), and pacifier use (any); data were collected by maternal survey when the infant was aged 60 to 240 days.ResultsOf the 1600 mothers who were randomized to 1 of 4 groups (400 per group), 1263 completed the survey (78.9%). The mean (SD) maternal age was 28.1 years (5.8 years) and 32.8% of respondents were non-Hispanic white, 32.3% Hispanic, 27.2% non-Hispanic black, and 7.7% other race/ethnicity. The mean (SD) infant age was 11.2 weeks (4.4 weeks) and 51.2% were female. In the adjusted analyses, mothers receiving the safe sleep mobile health intervention had higher prevalence of placing their infants supine compared with mothers receiving the control mobile health intervention (89.1% vs 80.2%, respectively; adjusted risk difference, 8.9% [95% CI, 5.3%-11.7%]), room sharing without bed sharing (82.8% vs 70.4%; adjusted risk difference, 12.4% [95% CI, 9.3%-15.1%]), no soft bedding use (79.4% vs 67.6%; adjusted risk difference, 11.8% [95% CI, 8.1%-15.2%]), and any pacifier use (68.5% vs 59.8%; adjusted risk difference, 8.7% [95% CI, 3.9%-13.1%]). The independent effect of the nursing quality improvement intervention was not significant for all outcomes. Interactions between the 2 interventions were only significant for the supine sleep position.Conclusions and relevanceAmong mothers of healthy term newborns, a mobile health intervention, but not a nursing quality improvement intervention, improved adherence to infant safe sleep practices compared with control interventions. Whether widespread implementation is feasible or if it reduces sudden and unexpected infant death rates remains to be studied.Trial registrationclinicaltrials.gov Identifier: NCT01713868.
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Project description:BackgroundChronic insomnia (CI) is a mind-body disease that is commonly defined as a state of having disturbed daytime activities due to poor nighttime sleep quality. Baduanjin qigong (BDJQG) is widely used for CI in China. However, there is little scientific evidence to evaluate its effects on the hyperarousal state, which is closely associated with improved sleep quality.ObjectiveThe objective of the trial is to assess the therapeutic effects of BDJQG on sleep quality in patients with CI.MethodsA randomized controlled trial will be conducted on 86 patients, who will be divided into a BDJQG group and a cognitive behavioral therapy for insomnia group at a ratio of 1:1. Interventions in both groups will be given to the participants 7 times a week for 8 weeks, and the participants will be followed up for 4 weeks. The primary outcome is the change in the Pittsburgh Sleep Quality Index from baseline to week 8. The secondary outcomes are the changes in the Hyperarousal Scale, Insomnia Severity Index, Fatigue Scale-14, wrist actigraphy, salivary cortisol level, and functional magnetic resonance imaging from baseline to week 8. All main analyses will be carried out on the basis of the intention-to-treat principle.ResultsThis study was funded from January 2023. As of the submission of the manuscript, there were 86 participants. Data collection began in April 2023 and will end in January 2024. Data analysis is expected to begin in January 2024, with the publication of results expected in February 2024.ConclusionsThis study will present data concerning the clinical effects of BDJQG on CI. The results will help to demonstrate whether BDJQG is an effective therapy for improving sleep quality in association with a decreased hyperarousal level as a possible underlying mechanism. This study will provide much-needed knowledge for complementary and alternative therapy for patients with CI.Trial registrationChina Clinical Registration Agency ChiCTR2300069241; https://chictr.org.cn/bin/project/ChiCTR2300069241.International registered report identifier (irrid)PRR1-10.2196/53501.
| S-EPMC10751632 | biostudies-literature
Project description:BackgroundQuality improvement (QI) programs focused on mastery of content by individual staff members are the current standard to improve resident outcomes in nursing homes. However, complexity science suggests that learning is a social process that occurs within the context of relationships and interactions among individuals. Thus, QI programs will not result in optimal changes in staff behavior unless the context for social learning is present. Accordingly, we developed CONNECT, an intervention to foster systematic use of management practices, which we propose will enhance effectiveness of a nursing home Falls QI program by strengthening the staff-to-staff interactions necessary for clinical problem-solving about complex problems such as falls. The study aims are to compare the impact of the CONNECT intervention, plus a falls reduction QI intervention (CONNECT + FALLS), to the falls reduction QI intervention alone (FALLS), on fall-related process measures, fall rates, and staff interaction measures.Methods/designSixteen nursing homes will be randomized to one of two study arms, CONNECT + FALLS or FALLS alone. Subjects (staff and residents) are clustered within nursing homes because the intervention addresses social processes and thus must be delivered within the social context, rather than to individuals. Nursing homes randomized to CONNECT + FALLS will receive three months of CONNECT first, followed by three months of FALLS. Nursing homes randomized to FALLS alone receive three months of FALLs QI and are offered CONNECT after data collection is completed. Complexity science measures, which reflect staff perceptions of communication, safety climate, and care quality, will be collected from staff at baseline, three months after, and six months after baseline to evaluate immediate and sustained impacts. FALLS measures including quality indicators (process measures) and fall rates will be collected for the six months prior to baseline and the six months after the end of the intervention. Analysis will use a three-level mixed model.DiscussionBy focusing on improving local interactions, CONNECT is expected to maximize staff's ability to implement content learned in a falls QI program and integrate it into knowledge and action. Our previous pilot work shows that CONNECT is feasible, acceptable and appropriate.Trial registrationClinicalTrials.gov: NCT00636675.
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